B.S., Master's, or PhD in Biotechnology, Chemical Engineering, Biochemistry, Molecular Biology, or related field.
12+ years of experience in biotechnology, with 8+ years if holding a PhD, focusing on early-stage CMC operations for biologics.
Hands-on experience in early-stage development from pre-clinical to Phase 1/2.
Expertise in recombinant biologics, including CHO cell line development and process development.
Proven ability to manage external CDMOs and CROs effectively under tight timelines.
Experience in authoring Module 3 / CMC sections for IND/CTA submissions.
Strong communication and leadership skills, adaptable to a fast-paced startup environment.
Responsibilities
Identify and manage global CDMO and CRO partners for CMC activities.
Lead technical transfer and scale-up for Drug Substance and Drug Product manufacturing.
Direct development of formulations and analytical methods for complex antibody constructs.
Author and finalize CMC regulatory sections for clinical study approvals.
Provide technical oversight of CDMO/CRO activities and manage quality assurance processes.
Negotiate Statements of Work and manage the CMC operational budget.
Serve as the primary CMC authority, communicating progress and risks to leadership.
Benefits
Opportunity to lead high-impact CMC operations in a stealth-stage biotech company.
Engagement in advancing novel biologic assets into clinical studies.
Collaborative work environment with external partners and internal leadership.
Potential for significant career growth in a fast-paced startup setting.
Full Job Description
Job Description
POSITION SUMMARY
A well-funded, stealth-stage biotechnology company is seeking an experienced, hands-on Sr. Director / Vice President, Manufacturing and CMC. In this high-impact executive role, you will lead the operational execution and strategic direction of CMC activities for our pipeline of novel monoclonal and bispecific antibody programs.
We are at a pre-clinical stage and looking to advance multiple biologic assets into First-in-Human (FIH) Phase 1 and Phase 2 clinical studies over the course of our Series A funding. You will manage the execution of cell line development, formulation development, process development, and analytical development strictly in collaboration with our selected CDMO and CRO partners. RESPONSIBILITIES
Identify, select, and manage global CDMO and CRO partners. Directly oversee external execution of cell line development (CLD), upstream/downstream process development, formulation development, and analytical development for monoclonal and bispecific antibodies.
Lead technical transfer, scale-up, and non-GMP/GMP manufacturing of Drug Substance (DS) and Drug Product (DP) to support non-clinical GLP toxicology studies and Phase 1/2 clinical trials.
Direct CDMOs in developing stable liquid/lyophilized formulations and robust phase-appropriate analytical methods (characterization, release, and stability testing) tailored to complex bispecific and monoclonal antibody constructs.
Author, review, and finalize early-stage CMC regulatory sections (Module 3, IND / CTA filings) for Phase 1/2 clinical study approvals.
Provide hands-on technical oversight of CDMO/CRO activities. Review technical protocols, master batch records, analytical data, stability reports, and manage deviations, CAPAs, and change controls in partnership with Quality Assurance.
Review and negotiate Statements of Work (SOWs), RFPs, and service agreements with external vendors. Manage the CMC operational budget to support efficient timeline delivery through Series A milestones.
Serve as the primary CMC authority on internal leadership teams, translating technical progress, timelines, and risks clearly to executive leadership and scientific stakeholders.
EXPERIENCE & QUALIFICATIONS
B.S., Master's, or PhD in Biotechnology, Chemical Engineering, Biochemistry, Molecular Biology, or a related scientific discipline.
Minimum of 12+ years (8+ with a PhD) in the biotechnology industry, with a proven track record of leading early-stage CMC operations for biologics (specifically monoclonal and/or bispecific antibodies).
Extensive hands-on experience in early-stage development (Pre-clinical to Phase 1/2). Demonstrated success driving biologic assets from candidate selection through IND-enabling studies to initial clinical execution.
Deep technical expertise in recombinant biologics, including mammalian cell line development (CHO), process development (DSP/USP), complex characterization of bispecific formats, and formulation optimization.
Proven track record of selecting, contracting, and managing external CDMOs and CROs to deliver high-quality clinical supplies on tight timelines.
Exceptional communication and leadership skills with a "lead-by-example" mentality. Thrives in a fast-paced, lean, entrepreneurial startup environment where managing external execution is key.
